Back to resultsComparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
Primary Purpose
Gestational Diabetes, Glucose Intolerance During Pregnancy
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oral glucose tolerance test
Sponsored by
About this trial
This is an interventional diagnostic trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
Exclusion Criteria:
- Already diagnosed by diabetes mellitus
- Multiple pregnancy
Sites / Locations
- Ankara City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
50 gr-100 gr OGTT
75 gr OGTT
Arm Description
patients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT
patients are tested by 75 gr OGTT
Outcomes
Primary Outcome Measures
the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT
to determine the ideal diagnostic test
Secondary Outcome Measures
Full Information
NCT ID
NCT04585204
First Posted
October 9, 2020
Last Updated
February 18, 2022
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT04585204
Brief Title
Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
Official Title
Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Glucose Intolerance During Pregnancy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2282 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
50 gr-100 gr OGTT
Arm Type
Active Comparator
Arm Description
patients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT
Arm Title
75 gr OGTT
Arm Type
Active Comparator
Arm Description
patients are tested by 75 gr OGTT
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral glucose tolerance test
Intervention Description
Oral glucose tolerance test
Primary Outcome Measure Information:
Title
the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT
Description
to determine the ideal diagnostic test
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women
Exclusion Criteria:
Already diagnosed by diabetes mellitus
Multiple pregnancy
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seval Erdinç
Phone
00905054884144
Email
sevalerdinc@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
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